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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K250132

510(k) cleared

Ureteral Access Sheath

Zhejiang YiGao Medical Technology Co., Ltd. · Sep 5, 2025 · K250132

FDA cleared the Ureteral Access Sheath from Zhejiang YiGao Medical Technology Co., Ltd. on Sep 5, 2025 under K250132, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 17, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zhejiang YiGao Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250132?

K250132 is the FDA 510(k) for Ureteral Access Sheath, submitted by Zhejiang YiGao Medical Technology Co., Ltd.. FDA's decision date was Sep 5, 2025, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Ureteral Access Sheath?

Zhejiang YiGao Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K250132.

How long did the K250132 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Sep 5, 2025, 231 days later.

← All decisions in September 2025